On May 11, 2026 Sironax, a global clinical-stage biotechnology company developing transformative therapies for neurodegenerative, inflammatory and immunologic, metabolic, and rare diseases, reported that the U.S. Food and Drug Administration (FDA) has designated its SARM1 inhibitor SIR2501 as a Fast Track product for chemotherapy-induced peripheral neuropathy (CIPN). SIR2501 is a first-in-class allosteric inhibitor of SARM1, a key driver of nerve damage in a broad range of neurological diseases.

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The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions, fill unmet medical needs, and bring promising therapies to patients more quickly. Drugs granted this designation are eligible for more frequent interactions with the agency regarding development plans, a rolling NDA/BLA review, and potential priority review and accelerated approval.

"Fast Track designation for SIR2501 in CIPN is a meaningful recognition of the urgent unmet medical need and the potential of our entire SARM1 program," said Dr. Shefali Agarwal, Sironax President and CEO. "The FDA’s designation not only validates our approach in CIPN, but also the broader potential of SARM1 inhibition to address additional neurological diseases. We are inspired to advance this potential therapy for millions of patients around the world."

CIPN is a common nerve-damaging side effect of chemotherapy that affects the hands and feet. Symptoms include burning or shooting pain, loss of temperature and tactile sensation, muscle weakness, and impaired fine motor skills. A significant number of cancer patients receive high-risk chemotherapy (e.g., taxanes, platinum, vinca alkaloids), develop CIPN, and subsequently discontinue or reduce chemo regimen due to the disease.

"For too long, millions of cancer patients have found themselves in the difficult position of experiencing painful symptoms while receiving their cancer treatment," said Dr. Robert Coleman, Gynecologic Oncologist, Texas Oncology, and Chief Medical Officer of Vaniam Group; and one of the country’s preeminent gynecologic oncologists. "Unfortunately, the severity of these symptoms has led many patients to either curtail or completely stop their treatment regimens. I’m pleased that a potential treatment for CIPN is advancing that could at last address this condition."

About SIR2501
SIR2501 is a first-in-class allosteric inhibitor of SARM1, a key driver of nerve damage in diseases such as CIPN and amyotrophic lateral sclerosis (ALS). By binding SARM1 away from its active site and maintaining the enzyme in an inactive state, SIR2501 is designed to protect nerves and prevent degeneration, while avoiding potential adverse effects observed with orthosteric inhibitors. SIR2501 has demonstrated strong neuroprotective effects in multiple preclinical models, and global Phase 1b/2 clinical trials evaluating SIR2501 in patients with CIPN and ALS are ongoing.

(Press release, Sironax, MAY 11, 2026, View Source [SID1234665475])

On May 11, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the first quarter ended March 31, 2026, and provided an update on its recent corporate activities.

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"I am pleased to announce our new $1 billion share repurchase program and that we project to repurchase at least $400 million in 2026, which is a reflection of our strong cash generation and confidence in the long-term value and durability of our business. We started 2026 with exceptional momentum, highlighted by three new recent collaboration and licensing agreements with Vertex, Oruka and GSK, demonstrating the strong interest in Hypercon and ENHANZE and showcasing the real potential to exceed our goal of three new SC delivery platform deals this year. The two Hypercon multi-target agreements confirm the strong interest of biopharma companies to reduce injection volume through hyperconcentration and allow more flexible administration in the home. Our new multi-target agreement with GSK represents a significant opportunity for ENHANZE with multiple promising oncology targets, including its first potential application with antibody drug conjugates. This momentum creates durable new royalty opportunity beginning in the 2030s and extending to at least the mid-2040s," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme.

"The growing number of indications for our approved products and new Phase 3 data milestones represent increased opportunity for ENHANZE. Most recently, VYVGART Hytrulo was FDA-approved for all serotypes of generalized myasthenia gravis (gMG), representing a significant expansion of addressable patients. The VYVGART Hytrulo opportunity is further extended with positive Phase 3 data in ocular myasthenia gravis, increasing the MG addressable market by an additional 7,000 patients in the U.S. alone. Additionally, DARZALEX Faspro gained its 12th and 13th approved indications and expanded further in newly diagnosed and early second line multiple myeloma patients, the two largest, longer-duration of treatment patient populations. Takeda also announced positive Phase 2/3 data for its 20% immunoglobulin TAK-881 in patients with primary immune deficiency, creating the potential for the 11th ENHANZE product launch."

"Our opportunity with ENHANZE was further enhanced in the quarter by two new Phase 1 study starts, increasing the number of ENHANZE products in development to nine, well on our way to the expected 13 ENHANZE products in development by year-end 2026. We project these ENHANZE products have the potential for approvals beginning in 2029+, creating a new wave of royalty revenue. The five signed Hypercon agreements, which include the opportunity for 17 targets to be developed, with first approvals projected in the 2030/2031 time period represents a third exciting wave of new royalty revenue opportunity. This continued performance and progress resulted in strong first quarter financial results and we are pleased to reaffirm our 2026 outlook, including expectations for ENHANZE royalty revenue to exceed $1 billion for the full year," Dr. Torley concluded.

Recent Corporate Highlights:
•In May 2026, the Company announced a new share repurchase program to repurchase up to $1 billion of its outstanding common stock by December 31, 2028, with an expectation of buying back at least $400 million of shares in 2026.

Recent Partner Highlights:
•In May 2026, argenx announced U.S. Food and Drug Administration ("FDA") approval of a supplemental Biologics License Application ("sBLA") for VYVGART Hytrulo with ENHANZE for the treatment of adult patients with generalized myasthenia gravis ("gMG") including all serotypes – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
•In May 2026, Halozyme and GSK plc ("GSK") entered into a global collaboration and license agreement for ENHANZE with multiple oncology targets, including the first potential application in antibody-drug conjugates ("ADCs"). Under the terms of the agreement, GSK will make an upfront payment and potential future milestone payments and royalties on net sales of products developed with ENHANZE.
•In May 2026, Halozyme and Oruka Therapeutics, Inc. ("Oruka") entered into a global exclusive collaboration and license agreement for Halozyme’s Hypercon technology for use with ORKA-001, in development for psoriasis and related inflammatory diseases and one additional target. Under the terms of the agreement, Oruka will make an upfront payment and potential future milestone payments and mid-single digit royalties on net sales of products developed using the Hypercon technology.
•In May 2026, Takeda announced positive topline results from its pivotal Phase 2/3 trial of TAK-881 with ENHANZE in Primary Immunodeficiency Disease.
•In April 2026, Halozyme and Vertex Pharmaceuticals Incorporated ("Vertex") entered into a global exclusive collaboration and license agreement that provides Vertex access to Hypercon technology for use in up to three targets. Under the terms of the agreement, Vertex will make a $15 million upfront payment and potential future milestone payments and royalties on net sales of products developed using the Hypercon technology.

First Quarter Partner Highlights:
•In March 2026, Pfizer nominated a new undisclosed non-exclusive target to be studied with ENHANZE.
•In March 2026, Janssen announced the Committee for Medicinal Products for Human Use of the European Medicines Agency granted approval for self or caregiver administration of DARZALEX (daratumumab) SC formulation for patients living with multiple myeloma from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training, making it the first oncology injectable approved for self-administration in Europe.
•In March 2026, Janssen announced the FDA approved TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
•In February 2026, argenx announced positive topline results from the Phase 3 ADAPT oculus trial of VYVGART with ENHANZE in ocular myasthenia gravis.
•In January 2026, argenx initiated a Phase 1 study to evaluate ARGX-124 with ENHANZE.
•In January 2026, Janssen announced the FDA approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

First Quarter 2026 Financial Highlights:
•Total revenue was $376.7 million, compared to $264.9 million in the first quarter of 2025. The 42% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $240.7 million in royalties, an increase of 43% compared to $168.2 million in the first quarter of 2025, primarily driven by continued sales uptake of ENHANZE partner products that have launched since 2020, predominantly DARZALEX SC by Janssen, VYVGART Hytrulo by argenx and Phesgo by Roche in all geographies and contributions from other recently launched products.
•Cost of sales was $79.2 million, compared to $48.4 million in the first quarter of 2025. The increase in cost of sales was primarily due to an increase in bulk rHuPH20 sales.
•Amortization of intangibles expense was $29.5 million, compared to $17.8 million in the first quarter of 2025. The increase in amortization of intangibles expense was due to the acquisition of Elektrofi, Inc. ("Elektrofi") in November 2025.
•Research and development expense was $25.6 million, compared to $14.8 million in the first quarter of 2025. The increase was primarily due to the acquisition of Elektrofi and Surf Bio, Inc. ("Surf Bio") in the fourth quarter of 2025.
•Selling, general and administrative expense was $57.9 million, compared to $42.4 million in the first quarter of 2025. The increase was primarily due to an increase in consulting and professional service fees, including litigation costs incurred in connection with patent infringement litigation, the acquisition of Elektrofi and Surf Bio, and an increase in compensation expense.
•Operating income was $184.5 million, compared to $141.5 million in the first quarter of 2025.
•Net income was $150.0 million, compared to $118.1 million in the first quarter of 2025.
•EBITDA was $218.3 million, compared to $162.0 million in the first quarter of 2025. Adjusted EBITDA was $229.5 million, compared to $162.0 million in the first quarter of 2025.1
•GAAP diluted earnings per share was $1.22, compared to $0.93 in the first quarter of 2025. Non-GAAP diluted earnings per share was $1.60, compared to $1.11 in the first quarter of 2025.1
•Cash, cash equivalents, restricted cash and marketable securities were $320.9 million on March 31, 2026, compared to $145.4 million on December 31, 2025. The increase was primarily driven by cash generated from operations.

Financial Outlook for 2026
The Company is reiterating its 2026 financial guidance ranges, which were last provided on February 17, 2026.
For the full year 2026, the Company expects:
•Total revenue of $1.710 billion to $1.810 billion, representing growth of 22% to 30% over 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API.

•Revenue from royalties of $1.130 billion to $1.170 billion, representing growth of 30% to 35% over 2025.
•Adjusted EBITDA of $1.125 billion to $1.205 billion, representing growth of 71% to 83% over 2025, including new Hypercon and Surf Bio investment of approximately $60 million.
•Non-GAAP diluted earnings per share of $7.75 to $8.25, representing growth of 87% to 99% over 2025. The Company’s earnings per share guidance includes new Hypercon and Surf Bio investment of approximately $60 million and does not consider the impact of potential future share repurchases.

Table 1. 2026 Financial Guidance
Guidance Range
Total Revenue $1.710 to $1.810 billion
Royalty Revenue $1.130 to $1.170 billion
Adjusted EBITDA1
$1.125 to $1.205 billion
Non-GAAP Diluted EPS1
$7.75 to $8.25

1 EBITDA, Adjusted EBITDA and Non-GAAP Diluted EPS are Non-GAAP financial measures. See "Note Regarding Use of Non-GAAP Financial Measures" below for an explanation of these measures. Reconciliations between GAAP reported and Non-GAAP financial information for actual results are provided at the end of this earnings release.

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the first quarter ended March 31, 2026 today, Monday, May 11, 2026, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: View Source The call will also be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com.

(Press release, Halozyme, MAY 11, 2026, View Source [SID1234665437])

On May 11, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, reported positive interim results from the randomized, first-line Phase 2 portion of the HexAgon study. The trial evaluated the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC).

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HNSCC was selected as a proof-of-concept indication, as PD-1 monotherapy is active in this tumor type but leaves significant room for improvement. The trial design was modeled after KEYNOTE-048, focusing on patients with high PD-L1 expression (CPS ≥ 20) in order to further sharpen the ability to detect a treatment effect above checkpoint inhibition alone. A clear signal of added benefit in this study design would support INBRX-106’s potential to enhance checkpoint inhibitor efficacy across checkpoint inhibitor-sensitive indications.

The Phase 2 portion of the HexAgon study enrolled 68 patients: 33 randomized to the combination arm and 35 to the control arm. Baseline prognostic factors are largely balanced between both arms and the study is being conducted at over 80 sites in the United States, Europe and Asia. Today, the Company presented preliminary data from 53 patients (25 in the INBRX-106 combination arm and 28 in the control arm) with a data cutoff of May 7, 2026, representing the evaluable population for confirmed response, defined as patients who had either experienced confirmed disease progression or death, or completed at least two on-study tumor assessments. The remaining 15 patients in the overall population across both arms had not yet reached the maturity threshold for response confirmation or were not evaluable at the time of this data cut and were therefore not included in this analysis. Active unconfirmed responses and ongoing tumor increases/reductions are present in both arms, and these patients are expected to contribute to the final efficacy dataset in a subsequent update.

In the evaluable population, 11 out of 25 patients (44.0%) in the INBRX-106 combination arm achieved a confirmed objective response, compared with 6 out of 28 patients (21.4%) in the control arm. This represents a 22.6% absolute increase in confirmed responses. Three complete responses were observed in the INBRX-106 combination arm, reflecting tumor clearance, while no complete responses were observed with pembrolizumab alone. Complete responses in first-line HNSCC remain uncommon and are generally associated with more durable outcomes.

These clinical findings were supported by pharmacodynamic data, which showed up to a 15-fold increase in peripheral CD8+ and CD4+ T-cell proliferation and up to a four-fold increase in activation in INBRX-106 combination-treated patients compared with up to 2.5-fold and 1.5-fold increases, respectively, in those receiving pembrolizumab alone. The observation of robust systemic T-cell expansion and activation in combination-treated patients, alongside the clinical activity observed in this arm, is consistent with the expected mechanism of action of INBRX-106 as a potent T-cell costimulator.

The combination of INBRX-106 and pembrolizumab was generally manageable, with a safety profile consistent with the addition of an active immunostimulatory agent to checkpoint blockade. The most common treatment-related adverse events were rash, diarrhea, fatigue, and infusion-related reactions, which were predominantly low-grade. No treatment-related deaths were reported in either arm.

"We are greatly encouraged by these early clinical results," said Mark Lappe, Chief Executive Officer of Inhibrx. "These data, coupled with the clear evidence of T-cell expansion and superior depth of response, give us confidence that INBRX-106 could be the first costimulatory agent to fundamentally shift the efficacy ceiling of immunotherapy, and open the door to combinations with new modalities that could be enhanced by OX40 agonism."

Next Steps

The progression-free survival data from the Phase 2 portion of the HexAgon study are expected to become available in the fourth quarter of 2026. The Company plans to begin the Phase 3 portion of the HexAgon study during the third quarter of 2026.

Based on these promising early results, the Company also aims to evaluate INBRX-106 across broader indications to potentially improve the efficacy of checkpoint inhibitors. This strategy includes initiating a study in the perioperative setting in non-small cell lung cancer (NSCLC) later this quarter. The Company believes OX40 agonism has the greatest potential to drive cure in earlier-stage disease settings, where patients typically retain a more active and responsive immune system. In addition, the Company is beginning to plan for expansion into the front-line metastatic NSCLC setting, with studies expected to begin in 2027. Outside of combination with checkpoint inhibitors, the Company plans to explore combinations with agents that could benefit from T-cell costimulation, such as vaccines, T-cell engagers, and CAR-Ts.

About INBRX-106

INBRX-106 is a hexavalent agonist targeting OX40 (CD134), a costimulatory receptor on T-cells. Utilizing Inhibrx’s proprietary single-domain antibody (sdAb) platform, INBRX-106 is designed to achieve the high-order receptor clustering necessary for robust T-cell activation and survival, a feat that has eluded traditional bivalent antibody approaches. To date, over 175 patients have been treated with INBRX-106.

(Press release, Inhibrx, MAY 11, 2026, View Source [SID1234665460])

On May 11, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX) reported financial results for the first quarter ended March 31, 2026 and provided a business update.

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"The first quarter of 2026 reflects strong progress as we work to position ficerafusp alfa as the cornerstone of treatment in HPV-negative head and neck cancer. In addition to advancing our FORTIFI-HN01 pivotal trial, we continued to enroll patients in additional Phase 1b signal-seeking studies as we aim to unlock the full blockbuster potential of ficerafusp alfa. Based on recent FDA discussions, we plan to initiate a randomized study to evaluate a loading and every-three-week maintenance dosing regimen – further differentiating ficerafusp alfa and expanding optionality for patients and providers. We also look forward to sharing an important data update at ASCO (Free ASCO Whitepaper) 2026, which will further characterize the role of TGF-β in driving depth and durability of response across three 1L R/M HNSCC expansion cohorts," said Claire Mazumdar, Ph.D., Chief Executive Officer at Bicara Therapeutics. "Alongside our clinical progress, we are rapidly evolving toward becoming a commercial-stage company, and to support that evolution, today we announced several executive changes. David Raben has transitioned from Chief Medical Officer to a Senior Executive Advisor role after three years of instrumental contributions, and Bill Schelman, formerly Executive Vice President of Clinical Development, has stepped into the Chief Medical Officer role. We have also welcomed Chris Sarchi as our Chief Commercial Officer, who brings extensive oncology commercialization and leadership experience as we build toward launch."

First Quarter 2026 Highlights and Recent Progress

FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in First Line (1L) Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC)

Continued strong execution in FORTIFI-HN01, our pivotal trial in 1L HPV-negative R/M HNSCC; expect to be substantially enrolled by the end of the year to enable an interim analysis in mid-2027 to support potential accelerated approval.
Based on recent discussions with the U.S. Food and Drug Administration (FDA), the company plans to initiate a randomized clinical study that will evaluate ficerafusp alfa in combination with pembrolizumab, administered as a 12-week loading dose of 1500mg weekly (QW) followed by maintenance dosing of 2250mg every three weeks (Q3W). The company expects to initiate the study in the third quarter of 2026 to have results in time for potential U.S. accelerated approval.
Phase 1b Studies of Ficerafusp Alfa Across HNSCC and Other Solid Tumor Types

Continued to enroll multiple Phase 1b expansion cohorts to identify early proof-of-concept signals and inform ficerafusp alfa development strategy beyond 1L R/M HPV-negative HNSCC.
Published a manuscript detailing results from a Phase 1b expansion cohort evaluating 1500mg of ficerafusp alfa QW in combination with pembrolizumab in 1L R/M HNSCC in the Journal of Clinical Oncology. Read the manuscript here.
Corporate Highlights

Announced that effective May 8, 2026, Bill Schelman, M.D., Ph.D., previously the company’s Executive Vice President, Clinical Development, has succeeded David Raben, M.D., as Chief Medical Officer, and Dr. Raben has transitioned to serve as a Senior Executive Advisor. With this promotion, Dr. Schelman is responsible for medical affairs and clinical development. In his new role, Dr. Raben will advise on clinical development strategy across the company’s portfolio.
Announced that effective May 8, 2026, Chris Sarchi was appointed as Chief Commercial Officer. In this role, he will lead the commercial organization in preparation for launch readiness.
Key Anticipated Upcoming Milestones

HNSCC

Present long-term follow-up data, which will further characterizing the role of TGF-β inhibition in driving depth and durability of response, from three Phase 1b expansion cohorts of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from May 29-June 2, 2026 in Chicago, IL.
Other Solid Tumors, Including mCRC

Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ mCRC (RAS/BRAF wild type MSS) in the second half of 2026.
First Quarter 2026 Financial Results

Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, Bicara had cash, cash equivalents and marketable securities of $539.8 million, compared to $414.8 million in cash, cash equivalents and marketable securities as of December 31, 2025. The company received approximately $161.8 million in net proceeds from an oversubscribed public offering in the first quarter of 2026. Based on its current operating and development plans, the company expects that its existing cash, cash equivalents and marketable securities will fund operations into the first half of 2029.
Research and Development Expenses: Research and development expenses were $47.5 million for the first quarter of 2026 as compared to $34.3 million for the first quarter of 2025. The increase was primarily due to costs associated with the ongoing FORTIFI-HN01 pivotal trial, as well as the company’s ongoing Phase 1/1b dose expansion cohorts, and an increase in personnel costs.
General and Administrative Expenses: General and administrative expenses were $12.7 million for the first quarter of 2026 as compared to $7.5 million for the first quarter of 2025. The increase was primarily due to additional personnel costs and professional fees to support advancement of our clinical trials.
Net Loss: Net loss totaled $56.2 million for the first quarter of 2026 compared to $36.8 million for the first quarter of 2025.
Upcoming Investor Conferences

Bicara Therapeutics will participate in two upcoming investor conferences:

BofA Securities Health Care Conference 2026 on Wednesday, May 13, 2026 at 9:20 a.m. PT.
TD Cowen 7th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper) on Wednesday, May 27, 2026 at 10:30 a.m. ET.
A live webcast of the fireside chats will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. A replay of the webcast will be archived and available for 30 days following the event.

Conference Call Information

Bicara will host a live conference call and webcast at 8:30 a.m. ET today to discuss first quarter 2026 financial results and recent business activities. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the event.

(Press release, Bicara Therapeutics, MAY 11, 2026, View Source [SID1234665476])

On May 11, 2026 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three months ended March 31, 2026, and highlighted recent corporate updates.

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"Despite typical first-quarter seasonality and unusual weather-related disruption early in the quarter, we saw a clear recovery in February and March," said Craig Collard, Chief Executive Officer of Heron. "Our Acute Care franchise continues to perform with strong year-over-year growth, and we remain confident in our full-year framework as deferred elective procedures return and our commercial catalysts such as IGNITE 2.0, unique J-Codes, and planned sales force expansion for the Acute Care franchise continue to build through 2026."

"As environmental conditions normalized, we saw momentum rebuild through February and exited March with improved trends. We maintained disciplined cost management and expect temporary gross margin pressure to normalize as we work through higher-cost CINVANTI inventory over the next two quarters," said Ira Duarte, Executive Vice President and Chief Financial Officer of Heron.

Business Highlights

•
Heron generated total net revenue of $34.7 million in Q1 2026 and ended the first quarter with $44.8 million in cash, cash equivalents and short-term investments. The Company reaffirmed full-year 2026 guidance of net revenue of $173 million to $183 million and Adjusted EBITDA of $10 million to $20 million.

•
Acute Care franchise updates: Net revenue increased 32% year-over-year, including ZYNRELEF net revenue of $10.2 million and APONVIE net revenue of $3.4 million in Q1 2026.

•
Commercial expansion: Heron’s planned sales force expansion remains on track for Q3 2026, with recruitment underway to increase coverage and account depth across the portfolio.

ZYNRELEF:
•
Demand units increased by 22% year-over-year. IGNITE, the commercial alignment program for ZYNRELEF, demonstrated 111% growth in target accounts by year-end 2025. This success resulted in expansion of included target accounts in January 2026 by 40% and extension of the program throughout 2026 with IGNITE 2.0.

•
ZYNRELEF continues to benefit from NOPAIN Act reimbursement and an increasingly predictable payment experience among 110 million covered commercial lives as accounts increasingly apply the permanent product-specific J-code (J0668).

APONVIE:

•
APONVIE demand units increased 68% year-over-year. Accordingly, a key performance metric, Average Daily Units, in Q1 2026 increased 70% over Q1 2025.

•
APONVIE has gained P&T approval in 1,902 accounts totaling 5.8 million medium-to-high PONV risk procedures. Broad adoption of APONVIE continued, with ordering accounts increasing 67% year-over-year.

•
APONVIE’s permanent product-specific J-code (J8502) became active April 1, 2026, which further streamlines billing and supports broader access as utilization expands.

•
Fifth Consensus Guidelines for the Management of PONV included APONVIE as the only FDA-approved intravenous NK-1 antagonist for prevention of PONV in adults and elevated the role of NK-1 antagonists in multimodal prophylaxis strategies.

•
Oncology Supportive Care franchise updates: Net revenue was $21.1 million in Q1 2026, including CINVANTI net revenue of $20.5 million and SUSTOL net revenue of $0.6 million reflecting the previously communicated wind-down of SUSTOL by the end of 2026.

CINVANTI:

•
CINVANTI maintained 25% market share in the NK1 CINV category in Q1 2026, equivalent to the average of 25% for the past 12 months.

•
The REIGNITE program, with a goal of returning CINVANTI to steady growth, secured formulary wins and the near-term pipeline represents an increase of approximately $10 million net revenue on an annual basis in potential new opportunity.

•
Heron reached a settlement agreement with Baxter Healthcare Corporation in CINVANTI patent litigation, and the U.S. District Court for the District of Delaware dismissed the pending litigation between the parties on April 28, 2026.

•
Active promotion of CINVANTI as part of Heron’s planned expansion of its sale force for Q3 2026.

•
CINVANTI surpassed 5 million demand units sold since launch

•
Development update: The ZYNRELEF prefilled syringe (PFS) lifecycle program

•
This late-stage program to improve Operating Room efficiency with a Ready-to-Use product remains funded and on track. As previously announced, registration batches have been manufactured and placed on stability, and the Company will receive 12-month stability data in the first quarter of 2027. Heron is continuing CMC and device-related readiness activities to support the filing.

Financial Guidance for 2026

Item

2026 Full-Year Guidance for Net Revenue and Adjusted EBITDA

(in millions)

Net Revenue

$173 to $183 million

Adjusted EBITDA

$10 to $20 million

Cash, cash equivalents, and short-term investments were $44.8 million as of March 31, 2026.

Net Revenue Performance – Three Months Ended March 31

(in thousands)

(unaudited)

2026

2025

Dollar Change

Percentage Change

Acute Care

$ 13,629

$ 10,302

$ 3,327

32.3%

APONVIE

$ 3,394

$ 2,260

$ 1,134

50.2%

ZYNRELEF

$ 10,235

$ 8,042

$ 2,193

27.3%

Oncology

$ 21,082

$ 28,601

($ 7,519)

(26.3%)

CINVANTI

$ 20,535

$ 25,742

($ 5,207)

(20.2%)

SUSTOL

$ 547

$ 2,859

($ 2,312)

(80.9%)

Total Net Revenue

$ 34,711

$ 38,903

($ 4,192)

(10.8%)

Conference Call and Webcast

Heron will host a conference call and live webcast on Monday, May 11, 2026, at 8:30 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. The investor presentation to be used for the conference call and webcast can be accessed from Heron’s website prior to the conference call and webcast. An archive of the teleconference, webcast, and investor presentation will also be made available on Heron’s website for sixty days following the call.

(Press release, Heron Therapeutics, MAY 11, 2026, View Source [SID1234665438])